Behavioral coping skills training--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.

coping skills training

Behavioral Treatment 1 (coping skills training)--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.

amitriptyline

Amitriptyline: up to 1 mg/kg capsule taken once daily at bedtime. Taken up to Week 20. After Week 20 medications and doses may change with standard care.

Eligibility Criteria

Male or female participants from 10 years up to 17 years old.

Inclusion Criteria:
- diagnosis of chronic daily headache based on definition of 15 or more headache days
per month measured by a prospective daily headache diary
- females or males between the ages of 10-17
- PedMIDAS Disability Score > 20, indicating at least moderate disruption in daily
activities
Exclusion Criteria:
- medication overuse as defined in the ICHD-II criteria (NSAID or other simple
analgesic on ≥ 15 days/ month for >3 months; triptan intake in any formulation ≥ 10
days/month on a regular basis of ≥ 3 months)
- current treatment with amitriptyline
- no other current prophylactic antimigraine medication within a period equivalent to 140, indicating need for multi-systemic therapies to
address very significant level of disability
- youth who are pregnant, or those females who are sexually active and not using a
medically accepted form of contraception (barrier or hormonal methods) or do not
agree to be abstinent during the study
- disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates,
benzodiazepines, muscle relaxants, sedatives, tramadol

Additional Information

Official title

Drug and Non-Drug Treatment of Pediatric Chronic Headache

Principal investigator

Scott W. Powers, PhD, ABPP, FAHS

Description

Chronic daily headache (CDH)——defined as having headaches 15 or more days per month——is a
frequent and debilitating condition in children that results in severe decreased quality of
life and emotional stress. Very little is known about the most effective types of treatment
for CDH in children and adolescents. Development of effective interventions for youth with
CDH could potentially prevent the progression of a very painful and costly condition into
adulthood. Treatments combining pharmacological (drug) interventions with behavior change
have been found effective in treating adults with chronic pain, including headaches, but
have been understudied in children.
The goal of this randomized, controlled clinical trial is to determine the efficacy of
combined behavioral and drug treatment of CDH in youth ages 10 to 17. In the study,
scientists will investigate if a combination of pain coping skills training (CST) and the
drug amitriptyline (AMI)——CST-AMI——is effective in reducing headache frequency, functional
disability, and symptoms of depression. More specifically, the researchers will evaluate if
CST-AMI is superior to AMI combined with an attention control (ATT). The CST will mainly
focus on learning skills for coping with pain, and the ATT will focus on understanding
chronic headaches and lifestyle information.
Participants will be randomly assigned to one of the two treatment groups: CST-AMI or
ATT-AMI. Those assigned to CST-AMI will complete 8 weekly sessions of coping training and 2
monthly maintenance-promoting sessions. Sessions will focus on teaching biofeedback, muscle
relaxation techniques, imagery, distraction, activity pacing, problem solving, and calming
techniques, using a treatment manual developed and tested in youth with CDH. Those assigned
to ATT-AMI will receive the same amount of therapist support and attention but not the
active behavioral training. All participants will receive the study medication, AMI.
Headache frequency, functional disability, pain and headache characteristics, quality of
life, and symptoms of depression will be assessed before and after treatment, and reassessed
at 3, 6, 9, and 12 months. For participants, duration of the study——which includes
treatment and follow-up phases——lasts about 18 months. The treatment phase includes 12
study visits and the follow-up phase includes 4 study visits.
The long-term objective of this research is to establish effective treatments for CDH in
youth that lead to significantly reduced headache frequency and functional disability.

Trial information was received from ClinicalTrials.gov and was last updated in April 2011.